FDA Adverse Event
Malfunction
Summary report: N
ELECTRODE, DEPTH
MDR report key: 4901454
·
Received July 7, 2015
Report
- Report Number
- 2183456-2015-00005
- Event Type
- Malfunction
- Date Received
- July 7, 2015
- Date of Event
- January 25, 2015
- Report Date
- February 4, 2015
- Manufacturer
- AD-TECH MEDICAL INSTRUMENT CORP.
- Product Code
- GZL
- PMA / PMN Number
- K053358
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AD-TECH IS CURRENTLY IN THE PROCESS OF INVESTIGATING THIS ISSUE.
Description of Event or Problem · 1
AD-TECH RECEIVED AN EMAIL FROM A CUSTOMER STATING THAT DURING AN IMPLANTATION CASE, AN ISSUE WAS IDENTIFIED WITH A DEPTH ELECTRODE, WHERE THE STYLE COULD NOT BE REMOVED FROM THE ELECTRODE. THE ELECTRODE WITH STYLET WAS REMOVED FROM THE BRAIN. THERE WERE NO MEDICAL INTERVENTIONS REQUIRED. ANOTHER ELECTRODE WAS USED WITHOUT THE SAME ISSUE OCCURRING. IT WAS ALSO STATED THAT THE PT WENT ON TO CONTINUE HIS STAY IN THE MONITORING UNIT WITHOUT ANY PROBLEMS. AD-TECH'S COMPLAINT INVESTIGATION TEAM DETERMINED THAT AN MDR BE FILED FOR THIS ISSUE DUE TO A PRECEDENCE THAT WAS SET FOR FILING ON STICKING STYLET ISSUES BEGINNING WITH MDR 2183456-2015-00001.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 439523 | ELECTRODE, DEPTH | DEPTH ELECTRODE | GZL | AD-TECH MEDICAL INSTRUMENT CORP. | 208140568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |